Idiopathic Pulmonary Fibrosis (IPF)IPFO2NCT03050255
Short-term Effects of Supplemental Oxygen in Patients With IPF
A study testing Medical air, Oxygen (2Liter/min) and Oxygen (4Liter/min) in people with Idiopathic Pulmonary Fibrosis (IPF), run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
Although exercise-induced desaturation is frequently observed in patients with idiopathic pulmonary fibrosis (IPF) short-term effects of supplemental oxygen during walking have not been investigated yet. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- Medical air, Oxygen (2Liter/min) and Oxygen (4Liter/min)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with idiopathic pulmonary fibrosis and hypoxemia at rest or during exercise (PaO2 <55 mmHg or SpO2 <88%)
- Written informed consent
Who cannot join
- Forced vital capacity < 50% pred.
- Clinical signs of any cardial comorbidity
- Not able to walk
- Oxygen flow needed during exercise > 4l/min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Effects of Supplemental Oxygen During Walking in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis
Although exercise-induced desaturation is frequently observed in patients with idiopathic pulmonary fibrosis (IPF) short-term effects of supplemental oxygen during walking have not been investigated yet. Given, that walking ability is the most important activity of daily life, the aim of our study is to investigate the effects of supplemental oxygen on endurance walking capacity in hypoxemic IPF patients. In this study patients will perform 3 endurance shuttle walk tests (ESWTs) at 85% of their individual peak performance using medical air (=compressed room air, 2 liters/minute), 2 liters/minute oxygen, 4 liters/minute Oxygen in a double-blinded fashion and random order.
Since there are only limited pharmacological treatment options for IPF patients, this study may help to provide novel information about the short-term effects of supplemental oxygen. Furthermore it may help to investigate possibilities to optimize oxygen therapy in order to facilitate patients´ participation in activities of daily life and not at least to improve patients´ quality of life.
Read the detailed description
Rationale:
Exercise-induced desaturation is frequently observed in patients with idiopathic pulmonary fibrosis and predicts poorer outcomes. However, prospective studies with larger sample sizes and those investigating the effect of oxygen on endurance time, oxygen saturation and breathing frequency during walking are lacking. Given that walking is the most important activity of daily life to preserve the maintenance and to participate in social life, we aim to investigate the effects of supplemental oxygen during walking in IPF patients.
The endurance shuttle walk test (ESWT) is a well validated test with high reliability and validity for measuring endurance walking capacity in patients with chronic obstructive pulmonary disease (COPD). The advantage of this test in contrast to the 6-minute walk test is that the ESWT is performed at 85% of the individual maximum that is close to the intensity of typical daily activities. Additionally, by using the ESWT it is possible to determine the maximum duration of exercise and to compare values at isotime (= time point when the shortest of the 3 ESWTs ends), whereas values at the end of different six-minute walk tests (6MWTs) are not comparable in case of different distances.
Aim:
To investigate the short-term effects of supplemental oxygen on endurance capacity during walking (ESWT) in patients with idiopathic pulmonary fibrosis.
Design:
This study is a randomized, controlled, double-blinded cross-over trial. Following an initial incremental shuttle walk test (ISWT) in order to determine the individual maximum walking capacity, patients will perform 3 endurance shuttle walk tests (ESWT) at 85% of the maximal pace. In randomized order, patients will complete one ESWT on 2l/min oxygen, one on 4l/min oxygen and one on medical air (=compressed room air), whereas the patients as well as the investigator will be blinded to the gas mixture provided. All 3 conditions will be provided via nasal cannula. The time between the two ESWTs will be 24 hours in order to give enough time for regeneration. Endurance Walking capacity as measured by the ESWT will be used as the primary outcome.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- Medical air, Oxygen (2Liter/min), Oxygen (4Liter/min)
- Keywords
- supplemental oxygen, walking capacity, exercise capacity, endurance shuttle walk test
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical airOther
Oxygen (2Liter/min)Other
Oxygen (4Liter/min)Other
| Study group | Role | What they receive |
|---|---|---|
| ESWT order 1 | Experimental | Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order:
1. medical air (MA)
2. Oxygen (2 Liter/min)
3. Oxygen (4 Liter/min) Receives: Other: Medical air; Other: Oxygen (2Liter/min); Other: Oxygen (4Liter/min) |
| ESWT order 2 | Experimental | Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order:
1. medical air (MA)
2. Oxygen (4 Liter/min)
3. Oxygen (2 Liter/min) Receives: Other: Medical air; Other: Oxygen (2Liter/min); Other: Oxygen (4Liter/min) |
| ESWT order 3 | Experimental | Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order:
1. Oxygen (2 Liter/min)
2. Medical air (MA)
3. Oxygen (4 Liter/min) Receives: Other: Medical air; Other: Oxygen (2Liter/min); Other: Oxygen (4Liter/min) |
| ESWT order 4 | Experimental | Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order:
1. Oxygen (2 Liter/min)
2. Oxygen (4 Liter/min)
3. Medical air (MA) Receives: Other: Medical air; Other: Oxygen (2Liter/min); Other: Oxygen (4Liter/min) |
| ESWT order 5 | Experimental | Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order:
1. Oxygen (4 Liter/min)
2. Medical air (MA)
3. Oxygen (2 Liter/min) Receives: Other: Medical air; Other: Oxygen (2Liter/min); Other: Oxygen (4Liter/min) |
| ESWT order 6 | Experimental | Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order:
1. Oxygen (4 Liter/min)
2. Oxygen (2 Liter/min)
3. Medical air (MA) Receives: Other: Medical air; Other: Oxygen (2Liter/min); Other: Oxygen (4Liter/min) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance time (in seconds) measured by endurance shuttle walk test
Measured: Time until Patient terminates ESWT due to leg fatigue or dyspnea, up to 20 minutes
Secondary outcomes (5)
Change of breathing frequency during endurance shuttle walk test
measured by NOX-T3 (NoxMedical, Reykjavik, Iceland)
Measured: change from baseline to the end of the ESWT, up to 20 minutes
Change of Oxygen saturation during endurance shuttle walk test
continuous transcutaneous recording during endurance shuttle walk test via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Measured: change from baseline to the end of the ESWT, up to 20 minutes
Change of heart rate during endurance shuttle walk test
continuous transcutaneous recording during endurance shuttle walk test via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Measured: change from baseline to the end of the ESWT, up to 20 minutes
Change of partial pressure of carbon dioxide during endurance shuttle walk test
continuous transcutaneous recording during endurance shuttle walk test via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Measured: Change from baseline to the end of the ESWT, up to 20 minutes
Change of inspiratory capacity during endurance shuttle walk test
measured by Spiropalm 6MWT (Cosmed, Italy)
Measured: Change from baseline to the end of the ESWT, up to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study startNov 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Collaborators
- Linde AG
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
- Investigators
- Klaus Kenn, Prof., Principal investigator, Schoen Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050255
- Sponsor's protocol ID
- IPF-O2-Study
- Acronym
- IPFO2
- Status last verified
- Dec 2018
- First submitted
- 25 Nov 2016
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Supplemental Oxygen During Walking in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT03050255
- Acronym / sponsor ID
- IPFO2 / IPF-O2-Study
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Keywords
- supplemental oxygen, walking capacity, exercise capacity, endurance shuttle walk test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Collaborators
- Linde AG
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although exercise-induced desaturation is frequently observed in patients with idiopathic pulmonary fibrosis (IPF) short-term effects of supplemental oxygen during walking have not been investigated yet. Given, that walking ability is the most important activity of daily life, the aim of our study is to investigate the effects of supplemental oxygen on endurance walking capacity in hypoxemic IPF patients. In this study patients will perform 3 endurance shuttle walk tests (ESWTs) at 85% of their individual peak performance using medical air (=compressed room air, 2 liters/minute), 2 liters/minute oxygen, 4 liters/minute Oxygen in a double-blinded fashion and random order.
Since there are only limited pharmacological treatment options for IPF patients, this study may help to provide novel information about the short-term effects of supplemental oxygen. Furthermore it may help to investigate possibilities to optimize oxygen therapy in order to facilitate patients´ participation in activities of daily life and not at least to improve patients´ quality of life.
Detailed description
Rationale:
Exercise-induced desaturation is frequently observed in patients with idiopathic pulmonary fibrosis and predicts poorer outcomes. However, prospective studies with larger sample sizes and those investigating the effect of oxygen on endurance time, oxygen saturation and breathing frequency during walking are lacking. Given that walking is the most important activity of daily life to preserve the maintenance and to participate in social life, we aim to investigate the effects of supplemental oxygen during walking in IPF patients.
The endurance shuttle walk test (ESWT) is a well validated test with high reliability and validity for measuring endurance walking capacity in patients with chronic obstructive pulmonary disease (COPD). The advantage of this test in contrast to the 6-minute walk test is that the ESWT is performed at 85% of the individual maximum that is close to the intensity of typical daily activities. Additionally, by using the ESWT it is possible to determine the maximum duration of exercise and to compare values at isotime (= time point when the shortest of the 3 ESWTs ends), whereas values at the end of different six-minute walk tests (6MWTs) are not comparable in case of different distances.
Aim:
To investigate the short-term effects of supplemental oxygen on endurance capacity during walking (ESWT) in patients with idiopathic pulmonary fibrosis.
Design:
This study is a randomized, controlled, double-blinded cross-over trial. Following an initial incremental shuttle walk test (ISWT) in order to determine the individual maximum walking capacity, patients will perform 3 endurance shuttle walk tests (ESWT) at 85% of the maximal pace. In randomized order, patients will complete one ESWT on 2l/min oxygen, one on 4l/min oxygen and one on medical air (=compressed room air), whereas the patients as well as the investigator will be blinded to the gas mixture provided. All 3 conditions will be provided via nasal cannula. The time between the two ESWTs will be 24 hours in order to give enough time for regeneration. Endurance Walking capacity as measured by the ESWT will be used as the primary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ESWT order 1 | Experimental | Other: Medical air, Other: Oxygen (2Liter/min), Other: Oxygen (4Liter/min)Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order: 1. medical air (MA) 2. Oxygen (2 Liter/min) 3. Oxygen (4 Liter/min) |
| ESWT order 2 | Experimental | Other: Medical air, Other: Oxygen (2Liter/min), Other: Oxygen (4Liter/min)Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order: 1. medical air (MA) 2. Oxygen (4 Liter/min) 3. Oxygen (2 Liter/min) |
| ESWT order 3 | Experimental | Other: Medical air, Other: Oxygen (2Liter/min), Other: Oxygen (4Liter/min)Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order: 1. Oxygen (2 Liter/min) 2. Medical air (MA) 3. Oxygen (4 Liter/min) |
| ESWT order 4 | Experimental | Other: Medical air, Other: Oxygen (2Liter/min), Other: Oxygen (4Liter/min)Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order: 1. Oxygen (2 Liter/min) 2. Oxygen (4 Liter/min) 3. Medical air (MA) |
| ESWT order 5 | Experimental | Other: Medical air, Other: Oxygen (2Liter/min), Other: Oxygen (4Liter/min)Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order: 1. Oxygen (4 Liter/min) 2. Medical air (MA) 3. Oxygen (2 Liter/min) |
| ESWT order 6 | Experimental | Other: Medical air, Other: Oxygen (2Liter/min), Other: Oxygen (4Liter/min)Subject performs endurance shuttle walk tests (ESWT) under following conditions in the following order: 1. Oxygen (4 Liter/min) 2. Oxygen (2 Liter/min) 3. Medical air (MA) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients with idiopathic pulmonary fibrosis and hypoxemia at rest or during exercise (PaO2 <55 mmHg or SpO2 <88%)
- Written informed consent
Key exclusion criteria (4 listed)
- Forced vital capacity < 50% pred.
- Clinical signs of any cardial comorbidity
- Not able to walk
- Oxygen flow needed during exercise > 4l/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical air | Other | ESWT order 1, ESWT order 2, ESWT order 3, ESWT order 4, ESWT order 5, ESWT order 6 |
| Oxygen (2Liter/min) | Other | ESWT order 1, ESWT order 2, ESWT order 3, ESWT order 4, ESWT order 5, ESWT order 6 |
| Oxygen (4Liter/min) | Other | ESWT order 1, ESWT order 2, ESWT order 3, ESWT order 4, ESWT order 5, ESWT order 6 |
Primary outcome
Endurance time (in seconds) measured by endurance shuttle walk test
Time frame: Time until Patient terminates ESWT due to leg fatigue or dyspnea, up to 20 minutes
5 secondary outcomes
Change of breathing frequency during endurance shuttle walk test
Time frame: change from baseline to the end of the ESWT, up to 20 minutes
Change of Oxygen saturation during endurance shuttle walk test
Time frame: change from baseline to the end of the ESWT, up to 20 minutes
Change of heart rate during endurance shuttle walk test
Time frame: change from baseline to the end of the ESWT, up to 20 minutes
Change of partial pressure of carbon dioxide during endurance shuttle walk test
Time frame: Change from baseline to the end of the ESWT, up to 20 minutes
Change of inspiratory capacity during endurance shuttle walk test
Time frame: Change from baseline to the end of the ESWT, up to 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Kenn, Prof. principal investigator
Schoen Klinik Berchtesgadener Land
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical air, Oxygen (2Liter/min) and Oxygen (4Liter/min) in people with Idiopathic Pulmonary Fibrosis (IPF), run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance time (in seconds) measured by endurance shuttle walk test (time frame: Time until Patient terminates ESWT due to leg fatigue or dyspnea, up to 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.